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Using in vitro data to derive acceptable exposure levels: A case study on PBDE developmental neurotoxicity
Sherri Bloch1, Laura Lévêque1, Irva Hertz-Picciotto2
1Department of Occupational and Environmental Health, School of Public Health, Université de Montréal, Montreal, QC, Canada; Centre de recherche en santé publique, Université de Montréal and CIUSSS du Centre-Sud-de-l'Île-de-Montréal, Montreal, QC, Canada.
This study demonstrates that human in vitro data and biological modeling can successfully establish acceptable chemical exposure levels, offering a viable alternative to animal testing for assessing developmental neurotoxicity (DNT).
Area of Science:
- Toxicology
- Pharmacokinetics
- In vitro toxicology
Background:
- Traditional methods for determining acceptable chemical exposure levels rely on animal testing, which presents ethical concerns and may not accurately predict human health outcomes.
- Developing reliable alternatives to animal testing is crucial for advancing toxicological risk assessment.
- 2,2',4,4'-tetrabromodiphenyl ether (BDE-47) is a common environmental contaminant with known developmental neurotoxicity (DNT) concerns.
Approach:
- This study evaluated a novel approach using human in vitro data and biological modeling to determine acceptable exposure levels for BDE-47.
- Literature review identified sensitive in vitro assays for BDE-47 DNT, from which a point of departure was derived using benchmark dose modeling.
- Pharmacokinetic modeling and administered equivalent doses were used to estimate tolerable daily intakes and biomonitoring equivalents.
Key Points:
- A benchmark dose level (BMC05) of 164 μg/kg of cells was established for BDE-47-induced alterations in neural progenitor cell differentiation.
- Estimated tolerable daily intakes for BDE-47 ranged from 0.009–0.038 μg/kg/day.
- Derived biomonitoring equivalents for maternal serum were consistent with levels reported in human epidemiological studies.
Conclusions:
- The findings support the use of in vitro data and biological modeling as a robust alternative to animal testing for deriving acceptable exposure levels.
- This integrated approach offers a more ethical, efficient, and potentially more accurate method for human risk assessment.
- The study successfully established acceptable exposure levels for BDE-47, demonstrating the practical application of the proposed methodology.
